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FDA 510(k) Application Details - K974614
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
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510(K) Number
K974614
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK, NJ 07601 US
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Contact
STEVEN M KAY
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Regulation Number
892.1000
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Classification Product Code
LNH
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More FDA Info for this Product Code
Date Received
12/11/1997
Decision Date
03/04/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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